Imbio RV/LV Software
Imbio, LLC is listed for Imbio RV/LV Software (K203256). The FDA list gives March 9, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QIH as “Automated Radiological Image Processing Software”: To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203256
- Date of final decision
- March 9, 2021
- Company on the FDA list
- Imbio, LLC
- Lead panel
- Radiology
- Primary product code
- QIH
- openFDA device name for the code
- Automated Radiological Image Processing Software
- Device class
- 2
- Regulation number
- 892.2050
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.